India’s Granules will do a significant expansion of its API bulk drug site in Vishakhapatnam, and is getting substantial help from the International Finance…

The impending approval of Momenta's copy of Teva’s long-acting version of blockbuster Copaxone is now expected to be delayed.

Roche’s Genentech has sued Amgen for not giving up the info Genentech experts need to mount a patent infringement attack on Amgen’s biosimilar for Avastin, its…

President Trump told Robert Kennedy Jr. he won't "back down" from plans to create vax safety commission, despite guaranteed "uproar"…

Charles River Laboratories has unloaded QS Pharma, a Philadelphia-area CDMO, months after picking it up as part of its $585 million buyout of WIL Research.

In a warning letter, the FDA shows its dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness.

The FDA has banned products from an Australian company's plant in Guangzhou, China, and cited it with “significant violations” of cGMP regulations saying…

The FDA has again slammed a Japanese drug company in a warning letter, this time for not doing enough to prevent contamination during aseptic filling.

At the Conference on Retroviruses and Opportunistic Infections (CROI), GSK and Gilead present data on drug regimens that could be dueling blockbusters.

Manufacturing